Dear HM Senior Coroner Cox

Prevention of future deaths report following the Inquest into the death of Katie Emma Corrigan. Thank you for your Regulation 28 report to prevent future deaths issued following the inquest into the sad death of Katie Emma Corrigan.

Prevention of Future Deaths Report

Under Section 6 of your report entitled “Action that should be taken” you noted as follows in particular:

 The absence of a requirement for doctors in the private sector to contact a registered GP prior to dispensing opiate medication to a patient leaves the system open to abuse.  One of the on-line pharmacies identified above openly advertises itself as offering a ‘discreet’ service which I interpret as a willingness to circumvent the existing, inadequate controls. I do not know but am bound to wonder if there is a professional or financial relationship between the prescribing doctor and dispensing pharmacist and, if so, whether this is considered ethical or meeting current professional standards?  The Alert system appears cumbersome and ineffective.  All online prescribing services accessible by patients in England should be regulated by the CQC, regardless of which professional groups are doing HSCA Further Information Citygate Gallowgate Newcastle upon Tyne NE1 4PA

Telephone: Fax: 03000 616171

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the prescribing, regardless of where in the world those prescribers are registered, and regardless of where in the world the provider’s head office is. This would require a change in regulation by the Department of Health & Social Care.

CQC inspection of online provider services

As you are already aware the Care Quality Commission (CQC) is the independent regulator for health and social care in England. CQC’s purpose is to make sure health and social care services provide people with safe, effective, compassionate, high-quality care and we encourage care services to improve. CQC’s functions are to register health and adult social care service providers in England; to monitor, inspect and rate services; and to take action to protect people where appropriate using its powers under Health and Social Care Act 2008 and associated regulations.

As part of an online provider inspection CQC routinely checks the management of medicines, prescriptions, consent and sharing information with a patient’s other health care providers. CQC recognises that a provider’s management of medicines and prescriptions in this way can be restricted where patients have not provided consent to share information and/or where a patient has used alternative identification.

CQC has published guidance for providers1. The guidance describes the expectations of providers to ensure a patient’s GP is informed of prescribed medications from their service. We also expect that should the patient decline to consent for the sharing of such information to take place, the prescriber should consider whether it is still safe to continue and accept the full responsibility for their actions and act in line with GMC prescribing guidance.

All providers must comply with the regulations as set out in The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (RAR 2014). The regulations that would be most relevant to any reviews around online providers would be:

 Regulation 9 (Person-Centred Care);  Regulation 11 (Need for Consent);  Regulation 12 (Safe Care and Treatment including the safe use of medicines);  Regulation 13 (Safeguarding service users from abuse and improper treatment); and  Regulation 17 (Good Governance)

1 How CQC monitors, inspects and regulates ONLINE PRIMARY CARE, April 2019

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For all health and social care providers, CQC would look at the regulations outlined above and determine whether there is evidence of compliance under each of the Key Lines of Enquiry (KLOE) relative to the provider type.

A registered provider’s compliance with the regulations will be assessed at inspection. As part of a CQC comprehensive inspection the online provider will be inspected against five key questions, whether a service is safe, effective, caring, responsive and well led. Each of the five key questions are broken down into a further set of questions, the key lines of enquiry (KLOEs). When CQC inspects, these are used to help CQC decide what the inspection needs to focus on. For example, the inspection team will look at the management of medicines and prescriptions, consent, identity checks and sharing information with a patients’ other health care providers. As part of the consideration as to whether a service is safe, effective, caring, responsive or well led, CQC will consider how governance systems, processes and practices keep people safe, how these are monitored and improved and whether staff receive effective training in safety systems, processes and practices.

Online Provider Regulatory Framework Concerns:

CQC regulates providers of online primary care services based in England where they are delivering a regulated activity by an online means. This includes providers prescribing medicines in response to online forms. Providers of controlled drugs based in England must comply with legislation, which is enforced by CQC, as well as other healthcare regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA) and the General Pharmaceutical Council (GPhC). In addition, all healthcare professionals are subject to their respective codes of professional conduct and these are enforced by, for example, the GPhC for pharmacists or the General Medical Council (GMC) for doctors.

Through our regulation of independent online primary medical services, CQC has identified gaps in the regulatory framework for online providers. We share HM Coroner’s concerns that members of the public may be able to source medicines with the potential for harm from providers who structure their business in such a way as to be outside the scope of registration with the CQC or the GPhC. We are also aware that our regulatory partners, including MHRA and the GPhC, share our concerns about the lack of regulatory oversight in this area.

In the last few years, CQC has extensively engaged with members of a UK-wide cross-regulatory forum to improve oversight of these providers. Although CQC has taken enforcement action against online providers we also identify that our ability to regulate in this space in certain circumstances where we see unsafe or criminal practice is restricted by legislative barriers and limitations in this area. CQC recognises the regulatory framework in this area needs to be updated to address emerging risks and to ensure independent online prescribers adhere to safe practice.

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Since January 2021 CQC has been in discussions with, and submitted, proposals for legislative changes to the Department of Health and Social Care (DHSC), to improve CQC’s ability to take action against independent providers of online primary care services that are putting people’s lives at risk. In particular, we are looking to address safety gaps in the following areas:

 over prescribing of opioids and other medicines online;  prescribing online without knowledge of a patient’s history or access to patient records;  the type and quantities of medicines that can be prescribed by independent providers online;  the lack of measures and checks in place when medicines are dispensed in England, following a prescription from outside England; and  limited jurisdictional ability for UK regulators to take action in response to harmful prescribing by providers or registered persons based outside the UK.

DHSC are currently working with CQC to look at how regulation can be best updated to address the areas outlined above, as well as to address current and emerging threats to the health, safety and wellbeing of service users from online providers. This includes looking at what issues can be addressed through legislative change (primary and secondary). CQC is also looking to work more closely with our partners, other regulators (including MHRA and GPhC) and other government organisations to explore other opportunities for taking this work forward.

CQC Regulatory Action:

CQC has inspected each of the registered online providers that you identified from the inquest into Ms Corrigan’s death that Ms Corrigan may have used. At each inspection, management processes for prescribing medications were reviewed and if concerns were identified we took regulatory action against the provider or the inspection report shared details of the areas needing improvement.

We have identified that two of the online providers whose details you shared are not currently registered to carry on regulated activities. You may be aware that under section 10 Health and Social Care Act 2008 it is an offence for persons to carry on regulated activities without being registered with the CQC to do so. We are currently following our processes to investigate those providers you shared with us, to ensure these do not remain as unregistered providers and we may take enforcement action as appropriate and necessary upon conclusion of our enquiries.

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Where CQC identifies that regulations are not being met, we use our enforcement powers to require improvements to be made. We continue to do this and will share key learning and practice points from the inquest into the death of Katie Corrigan.

We hope that this response addresses your concerns. Should you require any further information then please do not hesitate to get in touch.

Dear Mr Cox Thank you for your letters of 17 February and 8 March 2021 about the death of Katie Corrigan. I would like to begin by saying how very sorry I was to read the circumstances of Mrs Corrigan’s death and my deepest sympathies are with her family and loved ones. While the great majority of medicines prescribed online are done so appropriately and safely, it is deeply concerning that patients, including Mrs Corrigan, have been able to access particular types of medicine, or medicines on a scale that they would not likely be prescribed by their GP, with serious, and sadly fatal, consequences. I would like to assure you that we are determined to do all we can to prevent such deaths from occurring again. I welcome the action by the Care Quality Commission (CQC) and the General Pharmaceutical Council (GPhC) to investigate the online providers identified by your investigation of Mrs Corrigan’s death. Where unsafe or criminal practice is identified it is essential that regulatory authorities take appropriate enforcement action within the range of enforcement powers available. The Department continues to work with healthcare regulators (the CQC), and the Medicines and Healthcare products Regulatory Agency (MHRA)), and professional regulators (the General Medical Council (GMC) and the GPhC), and others, to explore how the regulation of independent online prescribers can be strengthened.

Since 2017, a UK-wide regulatory forum, chaired by the CQC and including the relevant regulatory bodies, has considered a number of issues around digital health care provision, including independent online prescribers. The group meets regularly and collaborates in taking action to safeguard patient safety.

I am aware that you have received responses from the CQC and the GPhC, providing detail on those actions that include the provision of new and strengthened guidance, as well as regulatory activity, including enforcement action.

You may also wish to note that in relation to suppliers of medicines at a distance, following the UK’s departure from the European Union, the MHRA is considering, under powers in the Medicines and Medical Devices Act 2021, a replacement scheme of registration for suppliers of medicines at a distance which has been disapplied in Great Britain.

This is a complex issue and we recognise that there are remaining concerns about the ability of the regulatory framework to protect the public and improve the safety of online prescribing.

As you know, the CQC has identified proposals for legislative change to improve its ability to take action against independent online providers where there is unsafe practice and I can provide assurance that we will work with the CQC to consider these proposals carefully.

Conflicts of Interest

Turning to your concern about the potential for abuse in the relationship between a prescriber and a pharmacist, independent regulators of healthcare professionals have standards and guidance in place to ensure that financial arrangements between prescribing doctors and pharmacies are transparent and managed appropriately.

Guidance from the GMC is available to doctors on conflicts of interest1, as well as guidance on good practice2. The GMC’s guidance states that if a doctor, someone close to them, or their employer has a financial or commercial interest in an organisation providing healthcare, such as a pharmacy or dispensary, they must not allow that interest to affect the way they prescribe for, advise, treat, refer or commission services for patients.

With effect from April 2021, the GMC also has updated guidance on prescribing3, which places emphasis on following the principles of good practice regardless of the medium through which a consultation is taking place, face to face or online.

We would expect all registered pharmacies and pharmacists in England to meet the regulatory standards set by the GPhC when dispensing any lawfully valid prescription.

1 Financial and commercial arrangements and conflicts of interest (gmc-uk.org)

2 Good medical practice-english (gmc-uk.org)

3 Good practice in prescribing and managing medicines and devices (gmc-uk.org)

The GPhC has advised you of its standards for registered pharmacies4 and registered pharmacy professionals5, as well as guidance for providing services at a distance, including on the internet6. In addition, I am advised that the GPhC has initiated an investigation to consider this matter further and will share any findings and a decision once the investigation concludes.

NHSEI Alert System

In relation to the effectiveness of NHS England and NHS Improvement’s (NHSEI’s) alert system in preventing people from obtaining prescription-only medicines improperly, my officials have brought your concerns to the attention of NHSEI.

As you may already be aware, NHSEI has a clear responsibility in providing systems oversight for the management and use of controlled drugs. NHSEI’s Controlled Drugs Accountable Officers (CDAOs)7 undertake this role within each geographical region across England. They provide assurance that all healthcare organisations, including pharmacies, adopt a safe practice for appropriate clinical use, prescribing, storage, destruction and monitoring of controlled drugs.

CDAOs facilitate the routes to share concerns, report incidents and take remedial action as well as highlighting good practice. This is shared with wider partners such as clinical commissioning groups (CCGs) and the Police through the Controlled Drugs Local Intelligence Networks (CDLINs). Details of all CDAOs in England are held on a national register, which is owned and published by the CQC: www.cqc.org.uk/content/controlled- drugs-accountable-officers.

I am advised by NHSEI that on occasion, CDAOs share information about individual patients with relevant partners to support the safe management and clinical use of controlled drugs, including codeine. Circumstances where this may occur include where there is a credible concern that someone may be accessing controlled drugs inappropriately from several clinical services. I am further advised that information provided about individual patients is in line with the Caldicott principles8, and the individual’s freedom to choose how they access healthcare is balanced with the need for patient safety and public protection.

Controlled drugs regulations

Turning to the comments in your report about controlled drugs regulations, as your report identifies, decisions on the scheduling of controlled drugs under the relevant legislation are

4 standards_for_registered_pharmacies_june_2018_0.pdf (pharmacyregulation.org)

5 standards_for_pharmacy_professionals_may_2017_0.pdf (pharmacyregulation.org)

6 Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet (pharmacyregulation.org)

1 https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your-information/safety-and-quality/controlled- drugs-accountable-officer-alerts-etc/

8 The Eight Caldicott Principles — The UK Caldicott Guardian Council (ukcgc.uk)

taken by the Home Office. This is done with the provision of advice from the Advisory Council on the Misuse of Drugs. Any decisions must weigh up the risks of misuse, abuse and diversion, against not impeding legitimate use within healthcare. This Department works closely with health system leaders to provide evidence of safety and risk associated with medicines to help inform such decisions.

You highlight in your report that you have been advised that a change in the status of codeine linctus from a pharmacy medicine to a prescription-only medicine is needed.

I can confirm that the MHRA, the independent medicines regulator in the UK, is keeping the legal status of codeine, including codeine linctus, under review and will consider all sources of evidence and information relating to this issue.

In the last year, there has been increased police activity and enforcement action by the GPhC in relation to codeine linctus and its misuse in the preparation of a street drug. There is active engagement between this Department and the Home Office, and with relevant stakeholders including the MHRA, the CQC and the GPhC on this issue.

Categories of medicines where there is a risk of addiction, such as opioids, should only be supplied online if appropriate safeguards are in place to make sure they are clinically appropriate for patients. The GPhC has strengthened its guidance9 to UK online pharmacies which clearly states that the selling and supplying of medicines online carries risks that need to be appropriately managed to protect patient safety. Not taking appropriate steps to follow these guidelines can lead to failure to meet the standards of registered pharmacies, which can result in enforcement action.

Opioids

In relation to the wider context to this issue and the increasing concern internationally and here in the UK, about the overuse and misuse of opioids leading to a growing problem of dependence and addiction, I would like to outline the range of action that has been taken to protect patients from harm.

In 2017, the Government asked Public Health England to conduct an evidence review to identify the scale, distribution and causes of prescription drug dependence, and what might be done to address it. PHE’s report of the review was published in September 201910, providing evidence for dependence on, and withdrawal from, prescribed medicines, with the aim of making sure that local healthcare systems build awareness and support to enhance clinician and patient decision making.

In support of this, NHSEI is co-ordinating a programme to implement the recommendations of the review, working closely with relevant health system partners. The programme covers five classes of medicines including benzodiazepines; Z-drugs; gabapentinoids; opioids, for chronic non-cancer pain; and antidepressants.

9 Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet (pharmacyregulation.org)

10 Prescribed medicines review: summary - GOV.UK (www.gov.uk)

The MHRA recently reviewed the risk of addiction and dependence with opioid medicines, as a result of which, all opioid medications now carry prominent front-of-pack warnings that the product contains opioids and may cause addiction. In addition, warnings on the risk of dependence in product information have been strengthened and harmonised. The MHRA has also worked closely with stakeholders and Trades Associations to develop an additional, user-tested, safety information leaflet for distribution directly to patients at pharmacies and on the MHRA government website.

In addition, from October 2020, Primary Care Networks of GPs are required to identify and prioritise patients, including patients using potentially addictive pain management medication, who would benefit from a structured medication review11. You may also wish to note that further to the February 2020 update to the GP contract agreement 2020/21 to 2023/2412, a Quality Improvement Module in the Quality and Outcomes Framework for general practice on preventing prescription drug dependency is in development.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

NADINE DORRIES MINISTER OF STATE FOR PATIENT SAFETY, SUICIDE PREVENTION

11 Report template - NHSI website (england.nhs.uk)

12 Criteria for registration as a pharmacy technician in Great Britain (england.nhs.uk)